Black box warnings on medications

Imagine popping a cipro for your UTI, sitting down in the lazy boy and watching some tv, and as you got up to grab some Cinnamon Toast Crunch, your achilles tendon snapped. Ooof.

Once a drug is approved by the FDA and makes it to market, it is deemed safe and there’s no passive, simple way for the FDA to collect ongoing data about side effects or adverse outcomes. It truly depends on doctors, nurses, and patients to actively report what they think are bad things to the FDA. Once a drug has been approved, the FDA thinks it has done its job and it’s now up to the prescribers and users to alert that a drug is proving to be unsafe. 

And terribly unsafe drugs do happen. In 2005, Merck pulled a drug called Vioxx from the market. Vioxx caused between 88,000 and 139,000 heart attacks, 30 to 40 percent of which were probably fatal, in the five years the drug was on the market. Public Citizen, Ralph Nader’s consumer advocacy group, began petitioning the FDA 5 years prior to Merck withdrawing Vioxx claiming the drug was killing people. 

As a preventive medicine resident in 2006, I worked at Public Citizen. At the time, their healthcare group was an 8-member team and they were the only group in America acting as a full-time consumer watchdog group on the pharmaceutical industry. This blew my mind. For the entire US of A. 

I was the main author on a petition to the FDA requesting that the FDA mandate  a black box warning on all fluoroquinolones, a class of antibiotics including the popular drug, Cipro. Most drugs have a laundry list of side effects they are mandated to list. If one side effect is more severe than others, it’s included as “black box,” a design element intended to draw more attention to the particular serious side effect. Fluoroquinolones were causing healthy people’s tendons to rupture sometimes hours after taking the medication. That’s no good. Public Citizen saw an increase in reports of these tendon ruptures associated with this class of antibiotics and tasked me with writing the petition to the FDA. We were successful and a black box warning about tendon rupture was required on all of these antibiotics in this class in 2008. 

Fast forward 8 years, and the FDA issued a new alert last week announcing to patients that the risks of this class of medication outweigh the benefits when another class of medications is available. Change for the better happens in healthcare. And you can make it happen. It’s a long, drawn out procedure involving multiple people, persistence, and passion. But this is what makes healthcare people so great. Healthcare changemakers are the most passionate, patient, driven, and resilient people. They’re in it for the long haul. I’m proud to consider myself one.

P.S. I wrote another petition in 2007 to ban third generation oral contraceptives, one of the most popular class of oral contraceptives because they carry double the risk of blood clots. Last year, a friend of mine died from a blood clot while taking a third generation oral contraceptive.